LITESABER 2000

K993942 · Laser Dental Innovations · GEX · Jan 18, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K993942
• Device Name: LITESABER 2000
• Applicant: Laser Dental Innovations
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The LiteSaber™ 2000 indications for use are for the cleared indications for the laser system to which it is attached. For example, dermatological, ENT, general surgery, GYN surgery, oral/dental, maxillofacial, orthopaedic and podiatric procedures for the incision, excision, ablation, vaporization and hemostasis of soft tissue.

Device Story

LiteSaber™ 2000 is an after-market surgical laser accessory; functions as a replacement handpiece or tip for existing surgical laser systems. Device directs laser beam by clasping clad fiber (200-400 microns) and bending distal bare fiber into smooth radius; features 360-degree rotation for lateral or angled beam delivery. No internal optics; does not affect laser spot size or transmission. Used by clinicians in surgical settings (general, plastic, ENT, GYN, dental, orthopaedic, podiatric). Handpiece is reusable (steam autoclave); tips are disposable. Benefits include improved access and beam directionality without requiring refractive/reflective contact tips.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and functional comparison to the predicate device.

Technological Characteristics

Mechanical laser handpiece accessory; reusable handpiece assembly; disposable pre-curved tips. Accommodates 200-400 micron diameter clad laser fibers. Sterilization: steam autoclave (270°F for 30 minutes) for handpiece; tips are single-use. No internal optics, electronics, or software.

Indications for Use

Indicated for use in general, plastic, dermatologic, orthopaedic, intraoral, maxillo-facial, and dental soft tissue surgery, including marginal and interdental gingiva, for incision, excision, ablation, vaporization, and hemostasis. Compatible with existing surgical laser systems using clad fibers (200-400 microns diameter).

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Novatip Family of Laser Handpiece Tips (K971539)

Submission Summary (Full Text)

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Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

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- 1. Device Name:

| Device Trade Name: | LiteSaber™ 2000 |
|----------------------|-------------------------------------|
| Common Name: | Laser accessory |
| Classification Name: | Laser Instrument, Surgical, Powered |

#### Establishment Name & Registration Number: 2.

Name: Laser Dental Innovations, Inc. Number: Pending

#### Classification: 3.

| § 878.4810 | Laser surgical instrument for use in general and plastic surgery and in dermatology. |
|------------|--------------------------------------------------------------------------------------|
| § 874.4500 | Laser, ENT |
| § 874.4490 | Laser, Otolarngology |
| § 884.4550 | Laser, Surgical, Gynecological |

Device Class: Class II General and Plastic Surgery, OB/GYN, ENT, Dermatology Device Panels Classification Panel: Product Code(s): 79GEX, 77EWG, 77LMS, 85HHR respectively

- 4. Equivalent / Comparison Device:
- ー Novatip Family of Laser Handplece Tips, K971539 by Xanova Corp.

The Licesaber " 2000 tips function in the same way as the Novatip Laser Handpiece Thos. The Lites aber " 2000 operates with the same size fibers, and does not affect the spot size or the function of the laser beam. The materials used to construct the Licess ber 201 2000 are the same or are the functional equivalent of those used in the Novatip handpeice. The Licessaber™ sooo does not have a direct impact on the transmission of the laser energy because the handpiece includes no optics. The Lites aber 14 2000 is used to grasp and direct the laser fiber in clinically useful ways. Thus, it is believed that the Lices aber 14 2000 offers even less concern than the Novatip.

#### 10. Device Description:

Background. The Licesaber™ 2000 is an "after-market" accessory for use with an existing surgical laser system. The device may be used as a complete system (handpiece and tips) or just the tips may be used with an existing handpiece of the ultradent style. The LiceSaber™ 2000 is used as a direct replacement for the laser handpiece supplied as original equipment or the original equipment laser handpiece tip. The Licesaber™ 2000 is designed address the need to direct the beam in a direction other than straight through the handpiece. Further, it does so without the need for refractive or reflective contact tips. The Licesaber 2000 gently and effectively clasps the clad fiber while bending the distal bare fiber into a smooth radius. Pre-curved disposable tips channel the fiber. Precurved tips are available. The directional tips may be rotated 360 degrees. This allows the laser fiber to be directed laterally, up, down or any angle or radius in between. The tips are disposable and the handpiece is reusable.

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The Licesaber™ aooo laser handpiece is intended for use in general surgery, plastic surgery, dermatologic surgery, orthopaedic surgery, intraoral, maxillo-facial or dental soft tissue surgery including the marginal and interdental gingiva. The handpiece is "universal" in nature and is intended to be used in place of the handpiece supplied or provided by the laser manufacturer. The LiceSaber™ 2000 is designed to accommodate all clad laser fibers between 200 and 400 microns diameter.

Cleared indications for Use. The Licessber™ 2000 indications for use are for the cleared indications for the laser system to which it is attached. For example, dermatological, ENT, general surgery, GYN surgery, oral/dental, maxillofacial, orthopaedic and podiatic procedures for the incision, excision, ablation, vaporization and hemostasis of soft tissue.

# 5. Applicant / Sponsor Name / Address:

Laser Dental Innovations 745 Dubanski Drive San Jose, CA 95123 408.227.4674

# 6. Company Contact:

Mr. Howard Feinberg Laser Dental Innovations 745 Dubanski Drive San Jose, CA 95123 408.227.4674

### 7. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Ln., Suite C-100 Pleasant Hill, CA 94523-3389 925,358,2640 vox - 925,356.2654 fax

# 8. Sterilization Information:

The laser handpiece may be sterilized and/or re-sterilized until replacement is needed. After cleaning and inspection, standard steam autoclave processing at 270 dearees F. for 30 minutes will produce a sterility assurance level (SAL) of 10°. The tips are disposable and may not be resterilized.

The handpiece assembly must be washed, cleaned and rinsed thoroughly before resterilization. Hospital grade soap/detergent & water followed by sufface scrubbing are employed. Refer to cleaning and sterilization instructions supplied with the device. Thoroughly rinse the handpiece in clear running water. Sterifize un-assembled.

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Public Health Service

JAN 18 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Schlerf Laser Dental Innovations c/o Buckman Company, Inc. 200 Gregory Lane Suite C-100 Pleasant Hill, California 94523-3389

K993942 Re:

> Trade Name: LiteSaber™ 2000 Regulatory Class: II Product Code: GEX Dated: October 11, 1999 Received: November 19, 1999

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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Page 2 - Mr. David Schlerf

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Stupto Rluvels
Laurence E. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K993942 510(k) Number:

LiteSaber™ 2000 Device Name:

Indications for Use:

The Lite Saber™ 2000 indications for use are for the cleared indications for the laser system to which it is attached. For example, dermatological, ENT, general surgery, GYN surgery, oral/dental, maxillofacial, orthopaedic and podiatric procedures for the incision, excision, ablation, vaporization and hemostasis of soft tissue.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stypt Rhodes

Division Sign-Off Division of General Restorative Devices K993942 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over - The - Counter Use ___ (Optional format 1-2-96)

LiteSaberResp.doc

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